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Pharmacokinetics of two formulations of omeprazole administered through a gastrostomy tube in patients with severe neurodevelopmental problems.

13:14 EDT 30th July 2014 | BioPortfolio

Summary of "Pharmacokinetics of two formulations of omeprazole administered through a gastrostomy tube in patients with severe neurodevelopmental problems."

What is already known about this subject • In tube-fed patients with severe neurodevelopmental problems, omeprazole for the treatment of gastro-oesophageal reflux disease (GORD) often needs to be administered through the feeding tube. • In daily practice, various procedures are used to administer the commercially available, enteric-coated omeprazole-formulations through a feeding tube. • However, no bioavailability-data are available to support a rational choice between the available administration procedures. What this study adds • This study demonstrates a substantial interindividual variability in omeprazole pharmacokinetics after administration through the gastrostomy tube in patients with severe neurodevelopmental problems. • In most patients, plasma concentration time profiles seem more favourable with a suspension formulation than with a MUPS(®) formulation. • Consequently, there is no apparent advantage in choosing a MUPS(®) formulation over the more easily administered suspension formulation.
Aims: Omeprazole is often administered through a gastrostomy tube as either (1) a Multiple Unit Pellet System (MUPS(®) ) tablet disintegrated in water (MUPS(®) formulation), or (2) a suspension in 8.4 % sodium bicarbonate (suspension formulation). This bioavailability study evaluates this practice in tube-fed patients with severe neurodevelopmental problems. Methods: nonblinded, two-phase cross-over trial. Results: In 7/10 patients, bio-availability was higher for the suspension formulation than for the MUPS(®) formulation. Median (90% CI) area under the plasma concentration-time curve (AUC)-ratio (MUPS(®) over suspension) was 0.5 (0.06-2.37). Conclusions: In this population, omeprazole MUPS(®) formulation has no apparent advantage over the more easily administered suspension formulation.


Laboratory of Medical Biochemistry and Clinical Analysis, Ghent University, Harelbekestraat 72, 9000 Gent, Belgium Department of Pharmacy, Ghent University Hospital, De Pintelaan 185, 9000 Gent, Belgium Department of Paediatric Gastroenterology, Ghent Uni

Journal Details

This article was published in the following journal.

Name: British journal of clinical pharmacology
ISSN: 1365-2125


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